BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLADE IN KNEE ARTHRO PACK

    MDR report key: 6260964 · Received January 18, 2017

    Report

    Report Number
    1423395-2016-00053
    Event Type
    Injury
    Date Received
    January 18, 2017
    Date of Event
    December 20, 2016
    Report Date
    January 18, 2016
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    LRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A KNEE ARTHROSCOPY A BD MANUFACTURED BLADE FELL INTO THE SURGICAL SITE. AS THE SURGEON MADE THE INITIAL INCISION INTO THE KNEE, THE BLADE BROKE AND WAS LODGED IN THE PATIENT'S KNEE. THE SURGEON WAS ABLE TO REMOVE THE BLADE. THE PROCEDURE INCREASED FROM FIFTEEN MINUTES TO FIFTY-ONE MINUTES. THE BLADE WAS RETURNED TO MEDLINE AND THE COMPLAINT OF THE BLADE BEING BROKEN WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. BD THE MANUFACTURER HAS BEEN INFORMED AND WILL DO OWN INVESTIGATION.

    Description of Event or Problem · 1

    A BLADE FELL INTO A PATIENT'S SURGICAL SITE DURING A KNEE OPERATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44859 BLADE IN KNEE ARTHRO PACK LRO BECTON, DICKINSON AND COMPANY 16JK0172

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention